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Phase I Clinical Trial to Evaluate the Safety of Recombinant Mycobacterium Tuberculosis Fusion Protein (EEC) in Healthy Adults Aged 18-65 and Patients With Pulmonary Tuberculosis

NCT06224608 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-01-25

No results posted yet for this study

Summary

The study is to enroll 60 participants aged 18-65 years old, including 30 healthy subjects and 30 tuberculosis patients. Low-dose (2.5 μg/ml), medium-dose (5 μg/ml), and high-dose (10 μg/ml) studies will be conducted separately for healthy subjects and pulmonary tuberculosis patients, with 20 participants in each dosage group. Within 28 days after the skin test of the test drug, observations were made of reactions at the skin test site, reactions at non-skin test sites, concomitant medication, and any other physical discomfort (skin test site-specific reactions were recorded separately).

Conditions

Interventions

BIOLOGICAL

Recombinant Mycobacterium Tuberculosis Fusion Protein (EEC)

1.0ml/bottle, containing 2.5μg/ml low dose, 5μg/ml medium dose, and 10μg/ml high dose of active ingredient. Take 0.1ml and inject it into the center of the front 1/3 of the palm side of the forearm by the Montessori method Single dose administration.

Sponsors & Collaborators

  • Beijing Chest Hospital, Capital Medical University

    collaborator OTHER

  • Beijing Friendship Hospital

    collaborator OTHER

  • Chengdu CoenBiotech Co., Ltd

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-01-17
Primary Completion
2023-05-09
Completion
2023-05-09

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06224608 on ClinicalTrials.gov